Promising Results Reported for HIV Patients Suffering From Facial Wasting

NEW YORK, March 22 -- Physicians from leading plastic surgery and dermatology practices report positive results from HIV patients participating in a clinical trial of Radiesse(TM) synthetic injectable implant on facial wasting. The trial is intended to demonstrate the safety and effectiveness of this widely used tissue augmentation therapy as a treatment for the facial changes that socially stigmatize many HIV-infected patients.

Lipoatrophy, or facial wasting, is a condition caused by loss of fat tissue under the skin of the cheeks resulting in a gaunt appearance. It is often associated with the anti-retroviral therapies taken by HIV patients, and, in some cases, is so severe that patients discontinue therapy. Radiesse, developed by BioForm Medical, Inc., is being tested for restoration of facial volume in patients with Lipoatrophy and to assess patient satisfaction and improvement in quality of life. An estimated 150,000 to 350,000 patients may benefit from such treatment.

"Facial wasting continues to have a debilitating effect on many HIV patients' appearance causing them to withdraw from normal social activities," stated Stacey L. Silvers, M.D., practicing facial plastic surgeon in New York, N.Y. "This new application of Radiesse may provide an immediate and potentially prolonged effect compared to other available treatments, resulting in enhanced quality of life."

The FDA has already approved Radiesse for vocal fold augmentation and certain plastic surgery reconstruction applications. It is also being tested in a trial for the treatment of nasolabial folds.

"I was interested in this study, because I knew of Radiesse's success in other tissue bulking uses, and I never questioned its safety," added Silvers. "I have found the end results more natural than any other injectable filler on the market."

"This product has made a dramatic difference in my life," noted one of Dr. Silver's patients. "Before participating in the trial, I had become less and less social because of the hollow appearance of my face. Now I have new confidence and a more positive outlook on life."

"Radiesse seems to be a much-preferred treatment because of its longer duration over currently available products," commented Joseph Eviatar, M.D., F.A.C.S., of Chelsea Eye & Cosmetic Surgery Associates in New York, NY. "Patients notice immediate results and require fewer treatments."

Radiesse is composed of Calcium Hydroxylapatite ("CaHA") microspheres in a gel carrier. CaHA is a naturally occurring material in the body. "Because Radiesse is natural in makeup, the product has been proven safe in many applications and has been well received by patients who are reluctant to inject non-natural products into their bodies," added Eviatar.

BioForm Medical, Inc. is a privately held medical device company developing and commercializing injectable implant products for soft and hard tissue augmentation. The company is dedicated to improving patients' lives by providing high quality, innovative, safe and effective medical products for use in the aesthetic plastic surgery and urology markets. The company's corporate headquarters are located in San Mateo, CA, and its R&D and manufacturing facility is near Milwaukee, WI. For more information, please visit:
www.bioformmedical.com

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